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A Randomized Study to Evaluate FK962 in Subjects With Mild to Moderate Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
FK962
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject satisfies the criteria for the clinical diagnosis of probable AD Subject has a score =< 4 on the Modified Hachinski Ischemia Scale at the screening visit Exclusion Criteria: Subject has history or evidence of significant neurologic disease other than AD Subject has a history of stroke Subject has been treated for schizophrenia or recurrent mood disorder within the previous three years Subject has a hematologic or solid malignancy diagnosed within five years prior to study entry Subject has medically unstable COPD or asthma Subject has end stage CHF (NYHA Class III or IV) or unstable angina Subject has evidence of significant renal insufficiency Subject has insulin-dependent diabetes mellitus or HbA1C>8.5% at screening

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Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 12, 2004
Last Updated
June 6, 2012
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00087724
Brief Title
A Randomized Study to Evaluate FK962 in Subjects With Mild to Moderate Alzheimer's Disease
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study to Evaluate the Safety and Efficacy of FK962 in Subjects With Mild to Moderate Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of five fixed dosage levels of FK962 or placebo for 24 weeks in subjects with mild to moderate Alzheimer's disease. Patient visits are every six weeks with limited efficacy measurements at week 6 and 18.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
510 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
FK962

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject satisfies the criteria for the clinical diagnosis of probable AD Subject has a score =< 4 on the Modified Hachinski Ischemia Scale at the screening visit Exclusion Criteria: Subject has history or evidence of significant neurologic disease other than AD Subject has a history of stroke Subject has been treated for schizophrenia or recurrent mood disorder within the previous three years Subject has a hematologic or solid malignancy diagnosed within five years prior to study entry Subject has medically unstable COPD or asthma Subject has end stage CHF (NYHA Class III or IV) or unstable angina Subject has evidence of significant renal insufficiency Subject has insulin-dependent diabetes mellitus or HbA1C>8.5% at screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Investigational Site
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92656
Country
United States
Facility Name
Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Investigational Site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Investigative Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80249
Country
United States
Facility Name
Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Investigational Site
City
Darien
State/Province
Connecticut
ZIP/Postal Code
06820
Country
United States
Facility Name
Investigational Site
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Investigational Site
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Investigational Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Investigational Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Investigational Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Investigational Site
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Investigational Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Investigational Site
City
Sebring
State/Province
Florida
ZIP/Postal Code
33872
Country
United States
Facility Name
Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Investigational Site
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Investigational Site
City
Elk Grove
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Investigational Site
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
32401
Country
United States
Facility Name
Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Investigational Site
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740
Country
United States
Facility Name
Investigational Site
City
Manchester
State/Province
New Jersey
ZIP/Postal Code
08759
Country
United States
Facility Name
Investigational Site
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08855
Country
United States
Facility Name
Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Investigational Site
City
Lawrence
State/Province
New York
ZIP/Postal Code
11559
Country
United States
Facility Name
Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Investigational Site
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Investigational Site
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Investigational Site
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Investigational Site
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Investigational Site
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Investigational Site
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Facility Name
Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigational Site
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Investigational Site
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States
Facility Name
Investigational Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y3G8
Country
Canada
Facility Name
Investigational Site
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A5C8
Country
Canada
Facility Name
Investigational Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T5G1
Country
Canada
Facility Name
Investigational Site
City
Sydney
State/Province
Nova Scotia
ZIP/Postal Code
B1P1C6
Country
Canada
Facility Name
Investigational Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M4S5
Country
Canada
Facility Name
Investigational Site
City
North York
State/Province
Ontario
ZIP/Postal Code
M2J5A3
Country
Canada
Facility Name
Investigational Site
City
North York
State/Province
Ontario
ZIP/Postal Code
M6M3C5
Country
Canada
Facility Name
Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1G 4C3
Country
Canada
Facility Name
Investigational Site
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E6B4
Country
Canada
Facility Name
Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6M3Z5
Country
Canada
Facility Name
Investigational Site
City
Willowdale
State/Province
Ontario
ZIP/Postal Code
M2K2Z3
Country
Canada
Facility Name
Investigational Site
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T1A5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

A Randomized Study to Evaluate FK962 in Subjects With Mild to Moderate Alzheimer's Disease

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